No significant increase in Guillain-Barré syndrome after COVID-19 vaccination in adults: A vaccine adverse event reporting system study.

OBJECTIVE: To investigate the association between Guillain-Barré syndrome (GBS) and COVID-19 vaccination. BACKGROUND: On July 13, 2021, the US Food and Drug Administration (FDA) released a new warning that Johnson & Johnson COVID-19 vaccine could increase the risk of developing GBS. METHODS: The reporting rate of adult GBS after COVID-19 vaccination, ascertained with Brighton criteria, was compared with the reporting rate after other vaccinations during the same time period, and also compared with the reporting rate during control periods. Statistical methods such as proportion tests, and Pearson's chi-squared test were utilized to identify significant relationships. Self-controlled and case centered analyses were conducted. A machine learning model was utilized to identify the factors associated with a worse outcome defined as emergency room (ER) or doctor visits, hospitalizations, and deaths. RESULTS: The reporting rate of GBS after COVID-19 vaccination was significantly higher than after influenza and other vaccinations (49.7, 0.19, 0.16 per 10 million, p < 0.0001). However, the reporting rate was within the incidence range of GBS in the general population. Using self-controlled and case centered analyses, there was a significant difference in the reporting rate of GBS after COVID-19 vaccination between the risk period and control period (p < 0.0001). There was an estimated 0.7-1.7 per million excess reports of GBS within 6 weeks of COVID-19 vaccination. Machine learning model demonstrated that female gender and age between 18 and 44 are associated with worse outcome. No association was found between the onset interval of GBS and its prognosis. CONCLUSIONS: Although the reporting rate of GBS after COVID-19 vaccination was not statistically different than that of the general population, the increased reporting of GBS within the first 6 weeks after COVID-19 vaccination, more so than with other vaccinations, suggests that some cases of GBS are temporally associated with COVID-19 vaccination. However, there is a reduction in the reporting rate of GBS after other vaccines, compared to reporting rates pre-COVID-19, highlighting limitations inherent in any passive surveillance system. These findings warrant continuous analysis of GBS after COVID-19 vaccination. Further improvement of the machine learning model is needed for clinical use.

Base excess and lactate as prognostic indicators for patients treated by extra corporeal life support after out hospital cardiac arrest due to acute coronary syndrome.

OBJECTIVE: To examine whether values of arterial base excess or lactate taken 3 h after starting ECLS indicate poor prognosis and if this can be used as a screening tool to follow Extra Corporeal Life Support after Out Hospital Cardiac Arrest due to acute coronary syndrome. DESIGN: Single Centre retrospective observational study. SETTING: University teaching hospital general adult intensive care unit. PATIENTS: 15 consecutive patients admitted to the intensive care unit after refractory Out Hospital Cardiac Arrest due to acute coronary syndrome treated by Extra Corporeal Life Support. INTERVENTIONS: Arterial base excess and lactate concentrations were measured immediately after starting ECLS and every 3 h after. RESULTS: Both base excess and arterial lactate measured 3 h after starting ECLS effectively predict multi-organ failure occurrence and mortality in the following 21 h (area under the curve on receiver operating characteristic analysis of 0.97, 0.95 respectively). The best predictive values were obtained with a base excess level measured 3 h after starting ECLS of less than -10 mmol/l and lactate concentrations greater than 12 mmol/l. The combination of these two markers measured 3 h after starting ECLS predicted multiorgan failure occurrence and mortality in the following 21 h with a sensitivity of 70% and a specificity of 100%. CONCLUSIONS: Combination of base excess and lactate, measured 3 h after starting ECLS, can be used to predict multiorgan failure occurrence and mortality in the following 21 h in patients admitted to an intensive care unit for refractory Out Hospital Cardiac Arrest due to acute coronary syndrome treated by Extra Corporeal Life Support. These parameters can be obtained simply and rapidly and help in the decision process to continue ECLS for refractory CA.